Currently browsing posts about: Food-safety

Thanks to Bill Marler for keeping us all up to date on the Daily Harvest saga.  He keeps up with the literature and writes, Is the Tara mystery closer to being solved?

My most recent post on this mystery was almost a year ago.

To review: Daily Harvest is a company that makes and ships preprepared vegan frozen meals, one of which, French Lentil + Leek Crumbles, has been recalled after several hundred people who ate it developed serious problems with their livers and gall bladders.

This was no trivial incident.  The FDA reported “As of 10/18/2022, there were 393 adverse illness reports in 39 states with 133 hospitalization and 0 deaths.”  But it could not detrmine the specific cause or route of contamination.

My post had breaking news:

The ingredient that caused the illnesses among people who consumed Daily Harvest’s French Lentil + Leek Crumbles has been identified, sort of.  As suspected, it’s the tara flour.  But what’s the toxin in the tara flour?  That, we still don’t know.

Now we have a new study: Is Baikiain in Tara Flour a Causative Agent for the Adverse Events Associated with the Recalled Frozen French Lentil & Leek Crumbles Food Product? A Working Hypothesis. 

In summary, the results of these initial studies support a working hypothesis that the adverse events reported by individuals consuming the Daily Harvest Crumbles product originate from the tara flour ingredient and are due, at least in part, to high levels of nonprotein amino acids (e.g., baikiain). It is further hypothesized that in vivo metabolism of metabolically unstable baikiain results in a toxic metabolite(s) that depletes glutathione and/or is an irreversible enzyme inhibitor (for L-pipecolate oxidase), resulting in adverse events which are dependent on the dose consumed and potentially exacerbated for individuals that have specific genetic predispositions.

Baikiain, which I had never heard of, is an analog of the amino acid proline.  In bacteria, it catalyzes proline destruction.  If it does this in humans, it also might account for the liver toxicity experienced by people who ate the Daily Harvest frozen meals containing tara.

The authors of the tara flour study identified baikiain in the flour.  They gave baikiain to mice, who did not fare well with it.

The hypothesis here is that some people are more susceptible to the toxic effects of baikiain than others.  The French Lentil + Leek Crumbles were sent to 26,000 customers, of which 400 or so got sick, more than 100 of them badly enough to have to be hospitalized; some required surgery.

The lesson here is that food ingredients need better testing.   Whoever makes tara must consider it GRAS (generally recognized as safe) for human consumption.

As Tom Neltner writes,

Tara flour is yet another example of how FDA’s GRAS program is broken—putting the health of Americans at unnecessary risk. FDA should use its big food reboot to fix the program so that we can have confidence in the safety of our food. The agency should also work with members of Congress who have introduced bills intended to fix GRAS and to have FDA reevaluate old food safety decisions in light of new science.

Amen to that.

My post last week on the FDA’s lack of action on ensuring the safety of infant formula elicited this response from Taryn Webb, Health Communications Specialist at CFSAN/FDA:

Hi Marion,

In your article below, “Alarming (in)action from the FDA,” you assert that “If FSMA did not require companies to notify the FDA when they found contamination, the FDA should be going to Congress to get that authority to announce its rulemaking to get that authority.” These statements could mislead readers to believe that the agency has not taken action to obtain this authority from Congress. In fact, the FDA is specifically seeking new authority to compel reporting of product positive test results for relevant pathogens (see FY 24 FDA Legislative Proposal titled, “Product Testing Requirements for Foods Marketed for Consumption by Infants and Young Children,” available at: https://www.fda.gov/about-fda/reports/budgets). Furthermore, the statement “FDA should…announce its rulemaking to get that authority,” is factually incorrect as without statutory authority, we are not in the position to undertake rulemaking to require such reporting. To reiterate what appears to be a point of confusion, the FDA cannot create authorities that we do not have through rulemaking. We did notice that you later updated your article at the very bottom to note that FDA did request such authority. However, your initial article and email distribution to readers contained incorrect information.

We are seeing a troubling pattern of articles with erroneous information that then get amplified. In the future, we would appreciate it if you contacted us before publishing articles that are solely about FDA so that we can provide you with the most up-to-date, correct information. You can reach out to our communications staff, which include myself and Jen Dooren (copied here) or by emailing CFSANTradepress@fda.hhs.gov.

As I see it, the “troubling pattern” here is FDA’s responses to advocates like me who want to support this agency’s role in making sure food companies in general—and infant formula companies in particular—do not produce unsafe food.  I want to encourage the FDA  to put public health as its first and immediate priority, as it is supposed to as an agency of the US Public Health Service.

I did not know about the FDA’s request to Congress.  The agency did not publicly announce it was asking for that authority.  I only learned about it from Helena Bottemiller Evich’s Food Fix newsletter, to which I subscribe.  I corrected my post as soon as I could.

Evich has her own issues with the FDA.  In her Food Fix letter last Friday, she said:

I updated last week’s post on FDA asking (not telling) infant formula makers to disclose contamination to clarify that the agency has determined it doesn’t have the authority to require this disclosure.  It’s perfectly normal for an agency to seek a clarification on something, as FDA did here, and I was happy to update the post – no problem. What I did take issue with, however, is FDA Commissioner Robert Califf characterizing the coverage as “misinformation” on Twitter.

…As I reported in Tuesday’s newsletter, FDA asked Congress last week for this test reporting authority in a budget document. This is notable, but it raises another critical question: Why didn’t the agency formally make this request earlier? It wasn’t in the agency’s budget request last year. It’s been more than a year since the massive Abbott Nutrition infant formula recall, and we’ve seen a handful of smaller recalls over Cronobacter concerns in recent months. And infant formula shortages and disruptions continue in many parts of the country.

If she didn’t know that FDA had asked Congress for test-reporting authority, it’s because the FDA wasn’t screaming for it as it should have been doing from the moment the infant formula crisis began.

The lives of infants are at stake.

Here what I wish the FDA had said from the beginning of the infant formula crisis and would still say:

“Marion, we are devastated by what has happened with infant formulas.  We can’t sleep for worrying about how we can protect infants from harm.  We are doing everything in our power to force formula producers to make sure their prevention controls are in place and monitored.  We never want this to happen again and won’t stop pushing them until we are sure infant formula is safe.”

I apologize for my error.  But I stand by my concerns.  FDA: If you want the troubling pattern to go away, fix the problem.

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Mars convinces emerging market consumers to eat more chocolate, the Financial Times reports.

Mars has embarked on a drive to convince developing country consumers to eat more chocolate, claiming it is on track to double the value of its confetionery sales in emerging markets in teh five years to 2024….”The amount of chocolate that an Indian or Mexican consumes is 10 times or less than a European…So there is a gigantic opportunity take that low…per capita consumption closer to Europe.”

[In response to a question about the health effects of eating more chocolate] “To continue to be a super successful snacking company, we need to evolve our portfolio…and offer choices….If you go to India, you go to Mexico right now, you will see new offerings [from] us that are playing at the lower price point that didn’t exist [before].”

Lead and cadmium could be in your dark chocolate,says Consumer Reports.

CR tested a mix of brands, including smaller ones, such as Alter Eco and Mast, and more familiar ones, like Dove and Ghirardelli.

For 23 of the bars, eating just an ounce a day would put an adult over a level that public health authorities and CR’s experts say may be harmful for at least one of those heavy metals. Five of the bars were above those levels for both cadmium and lead. Read more about how CR tested dark chocolate (PDF).

NCA [National Confectioners Association] issues statement on Consumer Reports study into heavy metals in chocolate and cocoa.

Chocolate and cocoa are safe to eat and can be enjoyed as treats as they have been for centuries.  The…guidelines cited in the Consumer Reports study are not food safety standards…cadmium and lead are present in cocoa and chocolate due to soil and that bean cleaning during processing cocoa beans reduces lead and cadmium in chocolate products.

[and, of course] Food safety and product quality remain our highest priorities and we remain dedicated to being transparent and socially responsible.

Hershey debuts plant-based Reese’s and chocolate bar: The confections, which will hit shelves in March and April, are made with oats. This will be the first time the company offers permanent products in the category.

Comment

I don’t particularly like dark chocolate anyway.  Milk chocolate will have fewer heavy metals because it contains less cocoa and the Consumer Reports article is quite clear on which chocolates have fewer heavy metals.

But all of these items are about how to sell more chocolate which, alas, is not exactly a health food.  Do people in Mexico and India need more chocolate in their diets?  of course not, but chocolate companies “need” more sales regardless of health consequences.

This is about profits to shareholders, not public health.

And of course chocolate has a place in healthy diets—just not one that requires eating more of it.

Food safety lawyer Bill Marler is calling for a new food agency on the grounds that the “FDA food reorganization plan is a “dismal failure.”

His campaign includes online advertisements, social media promotion, and survivors of foodborne illness coming to Washington DC to visit Congressional leaders and hand out “GET THE F OUT OF THE FDA” t-shirts. (Marler also will give free t-shirts to the first 100 people to request one at www.marlerblog.com—I’ve already asked for one)

Marler represents victims of food poisonings and thinks the FDA is not nearly as concerned about food safety as it needs to be because its primary focus is on drugs.

He’s also planning to run ads: “Food safety is suffering at FDA because the people at the top are doing drugs.”

He does have a sense of humor.  Marler is dead serious about cleaning up our ongoing, endless food safety problems.

Will this help?  Let’s hope.

Also

A separate food agency might be able to address what Bill Frist, Dan Glickman, and Jerold Mande are calling for: preventing unsafe food in all its manifestations, not only acute microbial, but also hyper-caloric.

Last week, the FDA announced its proposed Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities.   You can also watch this announcement on video.

This action comes in the wake of:

• The infant formula crisis [Contaminated formula made babies sick. The FDA was warned about food safety concerns at an Abbott plant but took no action.  Abbott recalled formulas,shut down the plant.  This led to empty shelves.  Abbott is now under criminal investigation].
• The FDA’s evaluation of its performance during the crisis [this didn’t say much about accountability]
• The evaluation of the FDA by the Reagan-Udall Foundation [it called for major structural changes]
• The resignation of Frank Yiannas, deputy FDA commissioner [which made clear needed changes were not going to happen]
• Bipartisan pressure from members of Congress to enact major reforms
• Pressure from Senators DeLauro and Durbin to enact reforms
• The Washington Post editorial calling for breaking up the FDA
• Pressure from food safety lawyer Bill Marler to put food back into the FDA and to make fundamental changes

The FDA proposal comes with a vision of how the redesign would work.

The complaints and pressures argued for appointing a senior FDA official in charge of all FDA food programs and units.  Instead, the FDA proposes to create a Human Foods Program encompassing some, but not all, FDA food units.

Most prominently missing is the Center for Veterinary Medicine which deals with food for farm animals and pets.  These, however, fully participate in the food system for humans; they eat most of US corn production and loads of byproducts of human food production.  The systems for humans and animals are inextricably linked.

The organizational chart will look like this.  It splits the food units and connects them with dotted lines.  Good luck with that.  That was precisely the problem with the previous organization.

This looks better than the previous organization chart but falls far short of the authority needed to solve the nation’s food safety problem.

What’s needed?

• Unification of food safety under a central authority that unites the functions of USDA and FDA (the Government Accountability Organization has been calling for that for decades).
• Short of that, high-level FDA authority over the entire food supply under its jurisdiction.
• And much more FDA attention to its public health as well as its safety functions.  It should be taking the lead on actions to prevent diet-influenced chronic diseases.

Hey, I can dream.

In the meantime, let’s see how the FDA’s new structure goes and who it hires into that key position in charge of human foods.

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Last week, the Washington Post editorial board gave its Opinion :  For the nation’s health, break up the Food and Drug Administration.

The Food and Drug Administration last year failed repeatedly to keep the nation’s babies safe from tainted formula. The baby formula fiasco was the latest in a long line of food crises that the agency was slow to catch and handle. But the deaths of babies and the desperation of parents trying to find enough food for their newborns shocked Congress, the public and the world into realizing just how broken the U.S. food-monitoring system had become.

The editorial cited:

• Helena Bottemiller Evich’s investigation in Politico, which found the FDA’s food-safety operations to be so slow as to be “practically in its own league.”
• A 2017 inspector general report finding the food recall system to be “dangerously sluggish.“
• Reports from the Government Accountability Office which have “repeatedly called out ‘high risk’ problems, including an urgent need for a national food-safety strategy and ‘high-level sustained leadership.'”

Bottemiller Evich is now doing her own invaluable newsletter, Food Fix (subscribe here, and  follow Food Fix on Twitter and LinkedIn).

In it, she says, “The FDA is not working if…”

• it takes a years-long struggle to set even interim, voluntary limits for heavy metals and other neurotoxins in baby food.
• its public health mission is to improve nutrition, but diet-related diseases continue to worsen unabated, driving massive human and health care costs.
• it takes more than a decade to address agricultural water safety…sparking deadly outbreaks year after year.
• it routinely fails to get to the bottom of serious food poisoning incidents – like last summer, when hundreds of people were sickened and more than 130 were hospitalized after eating Daily Harvest frozen crumbles.
• it is conducting fewer and fewer food safety inspections, even as Congress has given the agency more resources over the years to do more inspections.

The FDA says it is taking all this seriously and will come up with a plan to address these failings.  I can’t wait to see it.

Other comments

• Jerold Mande in the Washington Post: Food is making us sick. The FDA can do something about it.  
• Bill Marler asks: Hey FDA, its been over a month, are you going to do anything with the Reagan-Udall Foundation reccomendations?  Note: I discussed the Reagan-Udall report here.

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The Government Accountability Office has produced a “snapshot” on Healthy Eating: Government-wide solutions for promoting healthy diets, food safety, and food security.  It’s only two pages; take a look.

As of July 2022, many of our recommendations for developing strategies on healthy eating have not yet been addressed.

1. Strategy Needed to Address Diet-Related Chronic Health Conditions
Three diet-related chronic health conditions (cardiovascular diseases, diabetes, and cancer) were among the 10 leading causes of death in 2018, according to CDC. Men, Black or African Americans, and people living in southern states had disproportionately higher mortality rates from diet related conditions. Dietary changes could have prevented some of these deaths.

Additionally, in 2018, about three in four adults in the U.S. had excess weight, which can be associated with poor diet and lead to cardiovascular diseases, diabetes, and cancer.

The GAO recommends that the federal government establish leadership for strategies:

• On diet-related efforts
• Food-safety oversight
• Nutrition assistance programs to respond to emergencies

Excellent suggestions.  If only they could be implemented.

A review article finds it nontoxic.You may recall that on June 17,  Daily Harvest issued a recall of its frozen vegan Crumbles product  after 500 or so adverse event reports, many of  severe liver damage among the 28,000 customers who ordered it.

Here’s what the front of the package looked like.

This product has lots of ingredients:

organic butternut squash, organic hemp seeds, organic cauliflower rice, organic extra virgin olive oil, organic french lentils, organic red lentils, organic tri-colored quinoa, organic cremini mushrooms, organic tara flour, organic leeks, organic parsley, water, organic cassava root flour, organic flax seeds, organic sacha inchi powder, chia seeds, organic porcini powder, himalayan sea salt, organic apple cider vinegar, organic onion powder, nutritional yeast, organic garlic powder, organic tomato powder, organic white pepper, organic coriander seeds, organic mustard powder, organic thyme.

As food safety lawyer Bill Marler predicted, tara flour has been identified as the ingredient at fault.

• Tara is only in Crumbles and Crumbles is the only product that made people sick.
• Tara is also in another company’s product, Revive smoothies, that made people sick.

I had never heard of tara and had to look it up.  Since then, I’ve gotten curious and did some quick research.

Tara is a legume—a bean plant—grown in Peru and other Latin American countries.

Tara is grown for several purposes:

• Pod tannins for industrial leather, keeping ships free of marine animals, and preparing textiles to accept dyes
• Cosmetics (polysaccharides isolated from the seeds)
• Food additives—protein flours and gums (from the endosperm)

The research literature on tara is remarkably extensive (Who knew?).

On the tannins:

• Anything you want to know about tara tannins (from a doctoral dissertation)
• Use of tara tannins to prevent ship fouling

On cosmetics:

• Tara is safe as used in cosmetics.

On tara as a food ingredient:

• An overview from the International Food Additive Council implies that it’s safe
• A major safety evaluation in 1993 says it’s safe.
• It’s not toxic as used in traditional Peruvian medicine
• Another review article finds it nontoxic.
• It is neither mutagenic nor genotoxic
• It may have anti-cancer properties

From everything previously reported about tara over the past 20 years, there is no reason to think it might be unsafe.

So what’s going on?  How to explain “only” hundreds of cases of severe liver injury when 28,000 Crumbles meals were shipped during the time when cases were reported.

Possibilities:

• Some toxic ingredient accidentally or deliberately got into the tara flour (similar to melamine being substituted for wheat gluten in pet food in 2006 and in infant formula in China in 2008).
• Toxic tannins from other parts of the tara plant got into the endosperm flour.
• Some people have unusual sensitivities to tara proteins or digestive products of tara proteins (similar to what happens when people with coeliac disease eat gluten from wheat or other gluten-containing grains)
• Some people have inborn errors of metabolism that cause acute reactions to tara proteins (similar to what happens when people with deficiency of the enzyme glucose-6-phosphate dehydrogenase ingest fava beans)
• Others?  Could be, but I can’t think of any.

To prevent this from happening again, it’s necessary to identify the toxin.  I hope that happens soon.